Study to Predict Risk of Relapse in Bone Marrow Cell Samples From Younger Patients With Acute Myeloid Leukemia

NCT01438138 | Completed

• 4 other identifiers: AAML11B12CDR0000711851COG-AAML11B2NCI-2011-03465
• Study Type: observational
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: A screening test, such as My Profile Pediatric Assay, may help doctors predict a patient's risk of relapse and plan better treatment for acute myeloid leukemia. PURPOSE: This clinical trial is studying using the My Profile Pediatric Assay to see how well it works in predicting risk of relapse in bone marrow cell samples from younger patients with acute myeloid leukemia.

Conditions

Leukemia

Keywords

childhood acute myeloid leukemia in remission; recurrent childhood acute myeloid leukemia; untreated childhood acute myeloid leukemia and other myeloid malignancies; childhood acute basophilic leukemia; childhood acute eosinophilic leukemia; childhood acute erythroleukemia (M6); childhood acute megakaryocytic leukemia (M7); childhood acute monoblastic leukemia (M5a); childhood acute monocytic leukemia (M5b); childhood acute myeloblastic leukemia with maturation (M2); childhood acute myeloblastic leukemia without maturation (M1); childhood acute myelomonocytic leukemia (M4); childhood acute minimally differentiated myeloid leukemia (M0)

Outcome Measures

Primary Outcomes (1)

• Area under the receiver operating characteristic (ROC) curve of continuous score from the pre-specified classifier in predicting relapse after complete response to cytarabine- based induction chemotherapy

  A logistic regression model and area under the ROC curve for the model will be tested for significance against a null value of 0.5.

  Up to 3 years

Secondary Outcomes (1)

• Continuous score from the pre-specified classifier as a predictor of relapse after response to induction chemotherapy

  Up to 3 years

Study Arms (1)

Correlative studies

Archived bone marrow mononuclear cells are analyzed by single cell network proteomic profiling assay, the My Profile™ AML Risk of Relapse Assay. Molecular markers analyzed include Flt3-ITD, NPM1, and MRA. Results are then correlated with each patient's clinical data including patient's age, race/ethnic background, gender, treatment received, and outcomes.

Other: diagnostic laboratory biomarker analysis

Interventions

diagnostic laboratory biomarker analysis OTHER

Correlative studies

Correlative studies

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed non-M3 acute myeloid leukemia treated on COG-AAML03P1 or COG-AAML0531 protocols

DISEASE CHARACTERISTICS: * Patients with confirmed non-M3 acute myeloid leukemia * Treated on COG-AAML03P1 or COG- AAML0531 protocols * Samples from COG-AAML0531 can come from either treatment arm, but these samples need to be independent from any patients who donated samples assayed in study COG-AAML11B2 * Patients with Down syndrome are excluded * Cryopreserved bone marrow mononuclear cell (BMMC) samples collected at diagnosis, prior to start induction therapy * Samples must have been cryopreserved at central lab within 3 days of draw at clinical site * Target of 10 X 10\^6 cells frozen * Patients' clinical annotations required after unblinding PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

bone marrow

MeSH Terms

Conditions

Leukemia; Leukemia, Eosinophilic, Acute

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Leukemia, Myeloid

Study Officials

• Norman J. Lacayo, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2011
• First Posted: September 21, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2016-05